1. Field of the Invention
The present invention relates generally to vaginal douches and, more particularly, to vaginal douches and vaginal douche applicators for neutralizing vaginal odors by contact of vaginal tissue with a stainless steel surface of the applicators and to methods of vaginal douching.
2. Brief Discussion of the Related Art
In the area of female personal hygiene and gynecological health, vaginal douches have been proposed for reducing vaginal odors. Conventional vaginal douches typically involve the application of a stream of douching fluid through a vaginal douche applicator and into the vaginal canal of the user. Water alone as a douching fluid is not effective at significantly alleviating vaginal odors or the sources of vaginal odors, such as bacteria, when used in conjunction with vaginal douche applicators that do not have a stainless steel external surface. Since it is most typical for vaginal douche applicators to be made of inexpensive disposable materials, such as plastic, conventional vaginal douches usually include various commercial douching agents or substances, such as cleansing and/or disinfecting agents and/or perfumes, to be mixed with water by the user to obtain a douching fluid or supplied to the user as a prepared douching fluid. However, commercial douching agents or substances tend not to be effective in alleviating some vaginal odors or may serve merely to temporarily mask vaginal odors. Even when commercial douching agents or substances are effective in alleviating vaginal odors, the vaginal odors may return shortly after douching.
Another problem associated with conventional vaginal douches is that the douching agents or substances may cause irritation in some users and/or tend to alter the normal pH (acid/ alkaline) or chemical balance of the vaginal canal. When the vaginal canal becomes irritated and/or has its normal pH (acid/alkaline) or chemical balance disturbed or altered, an increased risk is presented for vaginitis, including yeast, bacterial vaginosis and other infections. Vinegar has been proposed as a natural douching agent or substance which, when mixed with water in the proper proportion, presents a douching fluid that closely mimics the normal pH of the vaginal canal. However, douching fluids consisting of vinegar and water tend not to be effective against vaginal odors for any meaningful length of time.
A further problem associated with conventional vaginal douches is that many vaginal douche applicators discharge douching fluid directly at and/or toward the cervix with sufficient force or pressure so that douching fluid may enter the cervical canal. When this occurs, vaginal debris such as bacteria and other harmful or undesirable organisms carried by the douching fluid may pass through the cervix and enter the uterine cavity, potentially causing pelvic inflammatory disease. Where douching fluid is not discharged toward the cervix and the upper portion of the vaginal canal, however, odors will not be eliminated or will quickly return since the cervix as well as the vaginal tissue produce odoriferous secretions. Hence, failure to wash off the cervix and the upper portion, or fornix, of the vaginal canal will yield an incomplete douching. An additional problem of conventional vaginal douches relates to the inadequacy of the vaginal douche applicators in maintaining an unobstructed gravity flow of douching fluid from the vaginal canal. Since the vaginal canal is normally collapsed or contracted, it has a tendency to clamp down on a vaginal douche applicator inserted therein. Accordingly, douching fluid containing vaginal debris may be prevented from exiting the vaginal canal and may collect and become trapped in the vaginal upper canal thereby allowing bacteria and other harmful organisms, including those responsible for sexually transmitted diseases, to remain in and move higher in the vaginal canal after douching. During douching, trapped douching fluid may build up in the vaginal canal with a sufficient pressure head that the douching fluid is detrimentally forced into and/or through the cervical canal. Conventional vaginal douches are also problematic for their failure to limit, regulate or control the flow of douching fluid into the vaginal douche applicators such that the douching fluid is discharged from the applicators at pressures high enough to force the douching fluid into the cervix. Other drawbacks to conventional vaginal douches are that the vaginal douche applicators are not designed for reuse and are actually unsuitable for reuse due to the difficulties involved in maintaining cleanliness for repeated use.
Although conventional vaginal douches may undesirably alter normal vaginal environments, douching has been found to benefit vaginal environments that are already undesirably altered or disturbed. Normal, balanced vaginal environments are characterized by trace numbers of yeast cells, trace numbers of coccoid bacteria called Gardnerella vaginalis and a preponderance of lactobacillus bacteria. Vaginal environments that are disturbed or unbalanced include those having an overgrowth of coccoid bacteria. Coccoid overgrowth is associated with bacterial vaginosis, characterized by an unpleasant odor and a change in consistency of vaginal secretions which adversely impact personal comfort and confidence. Inflamation associated with bacterial vaginosis may extend to the fallopian tubes and endometrium. Also, the production of amines, such as putrescine and cadaverine, by the coccoid bacteria may have carcinogenic effects, with there being a statistical association between coccoid overabundance and cervicitis and epithelial changes. The effects of bacterial vaginosis are believed to synergize with human immunodeficiency virus (HIV) and human papilloma virus (HPV). In the case of HIV, the presence of bacterial vaginosis may cause increased numbers of virus secreting cells and/or may enhance cell binding by the virus, thereby resulting in an increased risk for HIV transmission. In the case of HPV, the presence of bacterial vaginosis may result in the survival of oncogenic cell mutations related to cervical carcinoma. An excess of yeast cells may lead to problems, one such problem being fungal proliferation or yeast infections.
A relationship has been established between bacterial vaginosis and recent coitus. Since semen is alkaline, the normal pH of the vaginal canal increases significantly after coitus and changes from mildly acidic to alkaline such that the normal pH (acid/alkaline) of the vaginal environment is unbalanced or disturbed. This higher pH promotes a rapid increase in coccoid production and may result in coccoid overgrowth leading to bacterial vaginosis and its various adverse consequences. Accordingly, post-coital vaginal douching to wash away semen and/or coccoid bacteria may prevent bacterial vaginosis and/or counteract already existing bacterial vaginosis. However, because of the various problems associated with conventional vaginal douches, vaginal douching has not been widely adopted and used, particularly in the United States, as a preventative and/or treatment for bacterial vaginosis.
Elimination of vaginal odors by contacting vaginal tissue with a stainless steel surface of a vaginal douche applicator in the presence of water is proposed in U.S. Pat. No. 6,190,365 B1 to Abbott et al, the entire disclosure of which is incorporated herein by reference. The vaginal douche applicators and methods of vaginal deodorization disclosed by Abbott et al are effective in eliminating vaginal odors but can be rendered more effective at odor elimination by further maximizing contact between the vaginal tissue and the stainless steel surface of the vaginal douche applicator. Moreover, it would be desirable to further enhance the safety and efficacy of the applicators and methods disclosed by Abbott et al to increase medical and public acceptance of vaginal douching and, in particular, adoption of vaginal douching as a preventative and/or treatment for unbalanced vaginal environments.
Accordingly, it is a primary object of the present invention to overcome the aforementioned disadvantages of prior vaginal douches.
Another object of the present invention is to enhance the safety and efficacy of vaginal douches.
A further object of the present invention is to maximize contact of vaginal tissue with a stainless steel surface of a vaginal douche applicator.
An additional object of the present invention is to minimize alteration of normal vaginal environments as a result of vaginal douching.
Furthermore, it is an object of the present invention to minimize alterations in vaginal pH as a result of vaginal douching.
It is also an object of the present invention to break the chemical bonds of odoriferous compounds responsible for vaginal odors.
The present invention has as another object to create a controlled sheeting effect of douching fluid flow over a surface of a vaginal douche applicator.
A still further object of the present invention is to maintain a cleansing or rinsing flow of douching fluid out of the vaginal canal during vaginal douching.
Moreover, it is an object of the present invention to control the direction and force of douching fluid flow toward the cervix during vaginal douching.
Yet another object of the present invention is to prevent the accumulation of douching fluid in the vaginal canal during vaginal douching.
The present invention has as a further object to prevent the build-up of an undesirably high pressure head from douching fluid in the vaginal canal during vaginal douching.
Additionally, it is an object of the present invention to control the flow of douching fluid into a vaginal douche applicator to avoid discharging the douching fluid from the vaginal douche applicator into the vaginal canal at undesirably high pressures.
Still another object of the present invention is to achieve low pressure directional washing of the cervix and vaginal fornix with douching fluid during vaginal douching.
An additional object of the present invention is to produce a self-cleaning effect during insertion of a vaginal douche applicator into the vaginal canal to avoid transferring harmful organisms from the lower portion to the upper portion of the vaginal canal.
A still further object of the present invention is to promote medically safe reuse of a vaginal douche applicator.
The present invention has as an additional object to utilize vaginal douching as a preventative or a treatment for bacterial vaginosis.
It is also an object of the present invention to normalize disturbed vaginal environments by vaginal douching.
Some of the advantages of the present invention are that the reaction of the stainless steel surfaces of the vaginal douche applicators with odor-linked chemical bonds is maximized; the cervical os is not directly impacted with douching fluid; the vaginal douche applicators can illicit an antimicrobial reaction; effective deodorization of the vaginal canal may be achieved using only water as the douching fluid; the douching fluid may include treatment substances or additives, such as pH lowering, pH increasing, antibiotic, antiseptic, probiotic and/or microbicide substances or additives to obtain various effects or reactions; treatment substances or additives may be applied to the vaginal canal separately from douching using the vaginal douche applicators to apply the treatment substances or additives; the vaginal douche applicators provide a smearing or spreading effect such that treatment substances or additives may be more widely and more uniformly disbursed in the vaginal canal; desquamated cells, debris, bacteria and other harmful or undesirable organisms are flushed out of the vaginal canal; a xe2x80x9cleakyxe2x80x9d or imperfect seal is maintained between the vaginal douche applicators and the wall of the vaginal canal no matter how tightly the vaginal wall contracts around or clamps down on the vaginal douche applicators; the vaginal douche applicators are innately less expensive since they are reusable; post-coital douching is promoted since the vaginal douche applicators can be used repeatedly on demand; and the vaginal douche applicators may be provided with specialized coatings or finishes to obtain various reactions or effects.
These and other objects, advantages and benefits are realized with the present invention as generally characterized in a vaginal douche comprising a vaginal douche applicator for introduction in the vaginal canal and a source or supply of douching fluid connected with the vaginal douche applicator. The vaginal douche applicator comprises an applicator body, a head joined to the applicator body and an internal passage extending through the applicator body and terminating within the head. The applicator body comprises an open rearward end in communication with the passage, a forward end joined to the head and a plurality of external body channels along an external surface of the applicator body. The open rearward end is connectable with the source or supply of douching fluid, whereby douching fluid is supplied to the passage. The head comprises a plurality of rearward discharge holes in communication with the passage, a plurality of forward discharge holes in communication with the passage and a plurality of external head channels along an external surface of the head. The rearward discharge holes face proximally or rearwardly toward the applicator body such that douching fluid discharged therefrom is directed to flow along the interface between the applicator body and the vaginal wall. The forward discharge holes, which are spaced distally or forwardly from the rearward discharge holes, face distally or forwardly and face outwardly from the head at an angle so that douching fluid discharged therefrom is directed to flow toward the sides of the cervix. The head channels extend along the head in a direction transverse to a central longitudinal axis of the vaginal douche applicator, and the head channels direct discharged douching fluid toward the body channels. The body channels extend along the applicator body in the same direction as the central longitudinal axis of the vaginal douche applicator, and the body channels direct discharged douching fluid toward the vaginal opening for exit from the vaginal canal. In a particularly preferred vaginal douche applicator, the forward discharge holes face outwardly from the head at an angle of 30xc2x0 to the central longitudinal axis of the vaginal douche applicator; the head channels are disposed at an angle of 30xc2x0 to the central longitudinal axis of the vaginal douche applicator, with each forward discharge hole disposed in a respective one of the head channels; and the applicator body comprises a segment having an external cross-sectional configuration that tapers toward the forward and rearward ends of the applicator body. In a particularly preferred vaginal douche, the vaginal douche applicator has a stainless steel external surface and the douching fluid comprises water to effect neutralization of vaginal odors due to contact of the stainless steel with the vaginal tissue in the presence of water.
A method of vaginal douching according to the present invention is generally characterized in the steps of introducing a vaginal douche applicator through the vaginal opening into the vaginal canal, supplying douching fluid to an internal passage of the vaginal douche applicator, discharging the douching fluid into the vaginal canal through forward discharge holes in a head of the vaginal douche applicator such that the douching fluid is directed to flow toward the sides of the cervix, discharging the douching fluid into the vaginal canal through rearward discharge holes in the head such that the douching fluid is directed to flow over a body of the vaginal douche applicator in the direction of the vaginal opening, directing discharged douching fluid along external head channels of the head such that discharged douching fluid is directed toward external body channels of the body, directing discharged douching fluid along the body channels in the direction of the vaginal opening such that discharged douching fluid exits the vaginal canal, and withdrawing the vaginal douche applicator from the vaginal canal. In a method of vaginal deodorization, a vaginal douche applicator having a stainless steel external surface is introduced in the vaginal canal, the douching fluid comprises water and vaginal odors are neutralized due to contact of vaginal tissue with the stainless steel external surface in the presence of the water.
Other objects and advantages of the present invention will become apparent from the following description of the preferred embodiments taken in conjunction with the accompanying drawings, wherein like parts in each of the several figures are identified by the same reference characters.